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Study identifier: NCT06953869 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Recruiting

Evaluating the Effects of Tasimelteon vs. Placebo in Treating Pediatric Insomnia

Condition: Insomnia Disorder  ·  Sponsor: Vanda Pharmaceuticals

PhasePhase 3
Planned participants420
Who can joinAll sexes, 2 Years to 17 Years
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

This is a multicenter, double-blind, randomized study to evaluate the efficacy and safety of a daily single oral dose of tasimelteon and matching placebo in male and female pediatric participants with insomnia disorder.

This description comes directly from the study's public registry record.

Talk to the study team

Vanda Pharmaceuticals, Inc.  ·  202-734-3400  ·  VEC162@vandapharma.com

Always discuss trial participation with your own doctor first.

Locations (35)

Vanda Investigational SiteDothan, Alabama, United StatesRecruiting
Vanda Investigational SitePhoenix, Arizona, United StatesRecruiting
Vanda Investigational SiteIrvine, California, United StatesRecruiting
Vanda Investigational SiteMiami, Florida, United StatesRecruiting
Vanda Investigational SiteMiami Lakes, Florida, United StatesRecruiting
Vanda Investigational SiteWinter Park, Florida, United StatesRecruiting
Vanda Investigational SiteSnellville, Georgia, United StatesRecruiting
Vanda Investigational SiteStockbridge, Georgia, United StatesRecruiting
Vanda Investigational SiteNaperville, Illinois, United StatesRecruiting
Vanda Investigational SiteWorcester, Massachusetts, United StatesRecruiting
Vanda Investigational SiteGreat Falls, Montana, United StatesRecruiting
Vanda Investigational SiteLincoln, Nebraska, United StatesActive Not Recruiting

+ 23 more locations — full list on the registry record.

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